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Aurobindo Pharma's Eugia Unit-I Gets 4 USFDA Observations

Written By : Parthika Patel Published On 2026-02-28T21:00:59+05:30  |  Updated On 28 Feb 2026 9:00 PM IST
Aurobindo Pharmas Eugia Unit-I Gets 4 USFDA Observations
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New Delhi: Aurobindo Pharma Limited on February 27, 2026 announced the completion of a United States inspection at its subsidiary's facility, stating that the US Food and Drug Administration (USFDA) has concluded its inspection of Unit-I of Eugia Pharma Specialities Ltd. with four observations and no impact on operations.

The inspection was conducted at Unit-I, a formulation manufacturing facility situated at Kolthur Village, Shameerpet Mandal, Ranga Reddy district, Telangana (PIN 500078), from February 16 to February 27, 2026.

Also Read: Aurobindo's Eugia Arm Secures USFDA Nod for Transplant Drug Everolimus

As per the company’s regulatory filing, the USFDA inspection concluded with four observations. Eugia Pharma Specialities Ltd. will submit its response to the regulator within the stipulated timelines.

Importantly, the company clarified that there is no impact on its financials, operations, or other business activities due to the inspection outcome.

Aurobindo Pharma reiterated its commitment to maintaining the highest quality manufacturing standards across all its facilities globally and stated that it will keep the stock exchanges informed of any further developments related to the matter.

Also Read: Aurobindo Arm CuraTeQ Gets Health Canada NOC for Pegfilgrastim Biosimilar Dyrupe

aurobindo pharmaeugia pharmatelangana plantform 483 observationspharma inspectionusfda
Parthika Patel
Parthika Patel

    M. Pharm (Pharmaceutics)

    Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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